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Treatment Options

The choice of treatment is usually determined by a patient’s current inhibitor titer, or BU number. Bleeding in patients with low-titer inhibitors—that is, an inhibitor titer of 5 BU or less—can usually be controlled with higher-than-normal doses of replacement clotting factor to overcome or neutralize the inhibitor.¹

This treatment strategy may also stop bleeding in a patient with a high-responding inhibitor whose antibody titer has dropped to 5 BU or less. However, after a few days of factor replacement, the inhibitor titer may increase, and once it rises above 5 BU, clotting factor replacement can become ineffective, and another type of treatment called bypassing therapy is needed to control bleeding.²*

As their name implies, bypassing agents bypass the need for factor VIII by using other clotting factors to stop bleeding. Two bypassing agents are currently available: FEIBA VH, made by Baxter,³ and Recombinant FVIIa, made by Novo Nordisk.⁴

Some facts about FEIBA VH [Anti-Inhibitor Coagulant Complex]:^2,3

• It is produced from human plasma.
• It is also called an activated prothrombin complex concentrate, or aPCC.
• It contains clotting factors II, IX, X, and activated factor VII.
• It has been used for 30 years to effectively and safely control bleeding events in hemophilia patients with high-titer inhibitors.
• Drawbacks:
  • May not be effective for all patients or all types of bleeding episodes
  • Potential for thrombosis (undesirable clotting)

INDICATIONS

FEIBA VH [Anti-Inhibitor Coagulant Complex] is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. In addition, the use of FEIBA IMMUNO (AICC) has been described in a few non-hemophiliacs with acquired inhibitors to Factors VIII, XI and XII.

IMPORTANT SAFETY INFORMATION

• The use of FEIBA VH is contraindicated in patients who are known to have a normal coagulation mechanism.
• FEIBA VH is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses and theoretically the Creutzfeldt-Jakob disease (CJD) agent. This risk has been reduced by effective and stringent donor screening, testing for the presence of certain viral infections, and by inactivating and/or removing potential viruses.
• FEIBA VH should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. In rare instances, thromboembolic events may occur, particularly following the administration of higher than recommended doses and/or in patients with thrombotic risk factors. Infusion of FEIBA VH should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg of body weight. Anamnestic responses with rise in Factor VIII inhibitor titer have been observed.
• Allergic reactions associated with FEIBA VH have been reported. Symptoms may range from mild, short-term urticarial rashes to severe anaphylactoid reactions.
• Please review the FEIBA VH prescribing information for full prescribing details.

Full Prescribing Information [PDF]

Some facts about Recombinant FVIIa⁴

• It is a recombinant product.
• It contains activated clotting factor VII.
• It was first approved in the United States in 1999.
• Drawbacks:
  • May not be effective for all patients or all types of bleeding episodes
  • Potential for thrombosis

Please see full prescribing information for full prescribing details.

References

1. Ho AY, Height SE, Smith MP. Immune tolerance therapy for haemophilia. Drugs. 2000;60:547-554.
2. Leissinger CA. Prevention of bleeds in hemophilia patients with inhibitors: emerging data and clinical direction. Am J Hematol. 2004;77:187-193.
3. FEIBA VH. [package insert]. Westlake Village, Calif: Baxter Healthcare Corporation. April 2005.
4. NovoSeven Coagulation Factor VIIa R. [package insert]. Princeton, NJ: Novo Nordisk Inc. October 2006.

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Note: thereforyou.com does not recommend a particular treatment for specific individuals and recommends that you consult your hemophilia treatment center or physician before pursuing any course of treatment.